MAUDE Adverse Event Report: VOLCANO CORPORATION OMNIWIRE PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	89185J
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an omniwire was used in a diagnostic coronary procedure.During use, measurement drift was experienced outside the acceptable parameters.A new device was used to complete the procedure with no patient injury reported.This product problem is being submitted due to measurement drift.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block a6: race not provided.Block b6: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks e1 & g2: country is south africa.Blocks h3 & h6: the omniwire was not returned for evaluation, thus no returned product investigation was performed.Blocks h7, h9 & h10: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Additional Manufacturer Narrative
Blocks d9 & h3: the omniwire was returned for evaluation.Block h3: visual inspection found no unusual characteristics of the device.During functional testing, the device could not be zeroed, instead an error message appeared; therefore, the drift test could not be completed.However, the drift failure was confirmed based on the failed signal/zero test.Block h6: the probable cause of the reported failure, is a malfunction that prevented the unit from measuring stable pd values and curve.Manipulation and strain can damage internal components and result in the reported failure.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: OMNIWIRE PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 20591985
• Report Number: 3008363989-2024-00115
• Device Sequence Number: 15652558
• Product Code: DQX
• UDI-Device Identifier: 00845225003050
• UDI-Public: (01)00845225003050(11)240317(17)270317(10)0303144780
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K192886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 89185J
• Device Catalogue Number: 89185J
• Device Lot Number: 0303144780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F, CORDIS INTRODUCER SHEATH.; MEDTRONIC EBU 3.5 GUIDE CATHETER, SIZE UNK.; PHILIPS: CORE CONSOLE.
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic